Pfizer, Bristol-Myers Say Clot Drug Meets Goals

NEW YORK -- Bristol-Myers Squibb Co. and Pfizer Inc. on Thursday
said their blood thinner apixaban was more effective than
Sanofi-Aventis’ Lovenox in a late stage clinical trial.

The study compared the drugs’ ability to reduce blood
clots in the legs or lungs, also called venous thromboembolisms,
along with deaths in patients undergoing knee replacement
operations.

Apixaban is given by mouth, and is considered to be a potential
blockbuster drug. Enoxaparin is marketed under the names Lovenox
and Clexane.

Pfizer and Bristol-Myers said 40 to 60 percent of knee
replacement patients have a thromboembolism unless they receive
preventive care before surgery. Venous thromboembolisms include
deep vein thrombosis, or blood clots in veins that usually occur in
the leg, or a pulmonary embolism, or blood clot in the lungs.

In the trial, about 3,200 patients were given either 2.5
milligrams of apixaban twice a day, or a daily 40-milligram
injection of enoxaparin. The companies said 15.1 percent of the
apixaban patients had a thromboembolism, a nonfatal pulmonary
embolism, or died from any cause. For the enoxaparin patients, 24.4
percent had at least one of those events. That was significant
enough to meet the goals of the trial.

The data comes from around 2,000 of the patients in the
study.

Pfizer and Bristol-Myers said apixaban reduced the risk of major
venous thromboembolism by half. They said 1.1 percent of the
patients who took apixaban had one, compared to 2.2 percent of
patients on enoxaparin.

Apixaban did not significantly reduce bleeding.

The safety of the two drugs was said to be comparable, as both
drugs raised levels of a liver enzyme in about 2 percent of
patients.